This study evaluates the efficacy and feasibility of Carbon Nanoparticle Suspension Injection (CNSI) for Targeted Axillary Dissection (TAD) in breast cancer patients undergoing neoadjuvant chemotherapy (NAC), compared to traditional clip-based methods. By leveraging CNSI's enhanced visibility and stability, the study aims to improve the precision of lymph node removal, reduce surgical complications, and potentially transform clinical practices. Conducted across multiple centers, this randomized controlled trial focuses on clinical outcomes such as lymph node retrieval rates and the accuracy of surgical staging, aiming to establish a safer, more effective approach to managing axillary lymph nodes in breast cancer surgery.
Female patients aged 18 to 85 years are eligible.
Participants must have a histologically confirmed diagnosis of breast cancer, classified as cT1-4N1-2aM0 according to the 8th edition of the AJCC (American Joint Committee on Cancer) TNM classification system.
Eastern Cooperative Oncology Group (ECOG) performance status must be 0 or 1.
Clinical re-staging must indicate an axillary node status of ycN0 following NAC.
Patients with metastatic breast cancer (Stage IV).
Diagnosed with inflammatory breast cancer or bilateral breast cancer.
History of axillary surgical procedures.
Any medical, psychological, or social conditions that would prevent adherence to the study protocol or completion of the treatment or follow-up.
Parallel
Tissue Marker Clip
DeviceTissue Marker Clip to be Placed in Metastatic Axillary Lymph Node (Before Neoadjuvant Chemotherapy for Breast Cancer)
Carbon Nanoparticle Suspension Injection
DrugCarbon Nanoparticle Suspension Injection to be Placed in Metastatic Axillary Lymph Node (Before Neoadjuvant Chemotherapy for Breast Cancer)
Carbon Nanoparticle Suspension Injection
DrugCarbon Nanoparticle Suspension Injection to be Placed around Primary Tumor (Before Neoadjuvant Chemotherapy for Breast Cancer)
Lymph node retrieval rate marked
The proportion of successfully retrieved marked lymph nodes will be calculated and compared among the study groups to evaluate the effectiveness of each marking technique.
Number of sentinel and marked lymph nodes
The mean, median, and range of the number of sentinel and marked lymph nodes harvested during surgery will be recorded and compared to assess the efficacy of the marking techniques in identifying lymph nodes of interest.
Concordance between marked and sentinel lymph nodes
The consistency between marked lymph nodes and intraoperatively identified sentinel lymph nodes will be evaluated by calculating the percentage of marked nodes that are also sentinel nodes and vice versa.
Complication rate
All surgery-related complications, including but not limited to hemorrhage, lymphedema, infection, pain, tissue damage, clip displacement, clip loss, absence of CNSI staining, and excessive CNSI staining, will be recorded and analyzed. The overall complication rate and rates for specific types of complications will be reported. The severity of complications will be assessed using the Clavien-Dindo classification to provide a standardized evaluation of complication severity.
Axillary and distant recurrence rates
During the 2-year and 5-year follow-up periods, the axillary and distant recurrence rates will be monitored and reported for each study group to assess the long-term oncological outcomes of the different marking techniques.
Overall survival (OS), and disease-free survival (DFS)
OS and DFS will be monitored and reported for each study group at 2 years, 5 years, and other relevant time points. Kaplan-Meier analysis and Cox proportional hazards models will be used to estimate these endpoints and compare outcomes among the study groups.
Surgical duration
The total time from the start of the surgery to the removal of the last lymph node will be calculated to analyze the efficiency of different techniques in terms of surgical time.
Postoperative complications
Complications such as lymphedema, infection, and pain will be assessed at specific time points (e.g., 1 month, 6 months, and 1 year post-surgery) using validated tools or scales (e.g., Common Terminology Criteria for Adverse Events, Brief Pain Inventory) to determine the safety profile of each marking technique and its impact on patient morbidity.
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Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead sponsor
Zhejiang Provincial Natural Science Foundation of China
Collaborator
